The Effect of SPI (Surgical Pleth Index) - Guided Anaesthesia on Opioid Consumption in Gastric Sleeve Surgery

Last updated: May 22, 2023
Sponsor: Iuliu Hatieganu University of Medicine and Pharmacy
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

Intra-operative analgesia guided by SPI

Clinical Study ID

NCT05884229
1
  • Ages 18-65
  • All Genders

Study Summary

This is a unicentric, prospective randomised trial that aims to evaluate the role of intra-operative monitoring of nociception through SPI (Surgical Pleth Index) in guiding analgesia and reducing opioid consumption in obese patients undergoing bariatric surgery.

We aim to enrol 40 patients having laparoscopic gastric sleeve surgery in the Cluj-Napoca County Hospital. They will be randomised into two groups, one with opioid administration during surgery guided by SPI, and the other one guided by anesthetist experience. We will monitor opioid consumption, pain scores during the first 90 minutes post-operatively, hemodinamic events during surgery and the duration between reversal of neuromuscular block and extubation.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • patients scheduled to laparoscopic gastric sleeve surgery in First Surgical Clinic,Cluj-Napoca County Hospital

Exclusion

Exclusion Criteria:

  • drugs that affect the autonomic nervous system
  • peripheral neuropathy
  • altered renal/hepatic function
  • chronic opioid use
  • use of vaso-active drugs intra-operatively

Study Design

Total Participants: 40
Treatment Group(s): 1
Primary Treatment: Intra-operative analgesia guided by SPI
Phase:
Study Start date:
January 01, 2023
Estimated Completion Date:
January 01, 2024

Connect with a study center

  • First Surgical Clinic, County Hospital

    Cluj-Napoca,
    Romania

    Active - Recruiting

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